Efficacy of a Preparation based on Symbiotic Association Between Inulin, FOS, L. rhamnosus GG, Bromelin, Boswellia, Vitamin D3, Quercetin and L-tryptophan in Mild-to-Moderate Ulcerative Colitis: A Pilot Retrospective Multicenter Study.

BACKGROUND AND

OBJECTIVES

Several compounds based on short-chain fatty acids and/or probiotics/prebiotics have shown promising results in the therapy of mild-to-moderate ulcerative colitis (UC). The aim of the present study is to investigate the effectiveness of a preparation based on symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon in patients with active mild-to-moderate UC.

MATERIALS: andMethods: This was a multicentre, retrospective, observational cohort study between January 2023 and June 2023. Disease activity was assessed using the partial Mayo score. Patients were assessed at baseline, at 8-week, and 16-week follow-up (FU). The primary endopoint was clinical response, defined as a partial Mayo score reduction of at least 2 points, whereas C-reactive protein (CRP) and fecal calprotectin (FC) reduction at weeks 8 and 16 were secondary endpoints.

RESULTS

Data were collected at baseline from 17 UC patients (M 8, F 9). Median age at diagnosis was 48 years (IQR 20-80), and median disease duration was 10 years (IQR: 2-23). The clinical response at 8 and 16 weeks was observed in 9/17 (52%) and 11/17 (64%) patients, respectively (p =0.697). No difference was observed regarding CRP values, neither at week 8 nor at week 16. Concerning FC levels, we observed a significant decrease from baseline to week 8, from baseline values of 252 (76-359) μg/g to values of 98 (20-448) μg/g at week 8 (p <0.02); no difference was observed from baseline to week 16. Finally, no adverse events were observed during the study period.

CONCLUSION

In this preliminary study, the supplementation with the symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon offers real-world potential in controlling disease activity in patients with mild-to-moderate UC. Further multicentre, placebo-controlled, double-blind clinical trials are needed to validate our results on larger cohorts of patients with UC.